FDA Overruled on Peptide Policy Backed by Kennedy
The Health and Human Services Department has directed the FDA to stop enforcing rules against compounding pharmacies selling unproven wellness peptides, a move opposed by the agency's own scientific staff.
The Trump administration has acted to ease access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. The new Health and Human Services policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500, and KPV. This directive overrides FDA enforcement and reverses years of agency restrictions.
The policy faced overwhelming pushback among FDA drug staffers. They warned it could undermine the agency's long-standing mission of keeping unproven health products off the U.S. market. HHS officials moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.
FDA scientific pushback
FDA scientific staffers had little input on the decision and opposed the changes. A plan to give people easier access to these peptides was opposed by most FDA scientific staff members. The plan was driven almost entirely by HHS.
At a meeting in July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven for safety and effectiveness. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency's rigorous review process. FDA officials warned that the agency's scientific staffers had major safety concerns and would not support a regulation deeming them safe.
FDA staffers ultimately provided technical assistance in drafting the HHS plan. This included guardrails intended to improve safety. It is extremely rare for HHS to take the lead in drafting policies over the compounding industry. However, federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.
Safety measures and compounding history
The new approach includes specific guardrails. Besides sourcing ingredients from FDA-registered facilities, compounders will be directed to collect information on side effects for safety analysis and verify the chemical identity of peptides. HHS officials initially wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies.
This shift occurs against a history of compounding safety failures. The issue became a greater focus for the FDA after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry.
In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to risks. These risks include allergic reactions, kidney damage, and tumor growth.
Expert and industry reaction
Peptide advocates hail the move as a win for medical freedom, while critics warn it diverts patients from approved treatments. Kennedy has called himself a 'big fan' of peptides and previously described using BPC-157 to treat a muscle injury. According to the newly posted document, Kennedy determined the change 'advances patient choice and freedom' while protecting people from peptides sold online that are often made from unscreened ingredients.
Lee Rosebush of the American Academy of Peptide Medicine said in an online post that HHS had taken 'a huge step for patient and provider medical freedom.' A spokesperson for HHS said the agency is 'confronting the risks of black-market peptides' by giving Americans 'a more controlled alternative through licensed U.S. compounders.'
Critics see a dangerous precedent. The chemicals subject to the new policy have not been approved as safe and effective by the FDA. They are promoted for a wide range of medical uses.
Peter Lurie, a former FDA official, noted that the FDA has approved rigorously tested drugs for all of those conditions. He warned of consequences. "As people 'are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering,'" said Lurie, who now leads the nonprofit Center for Science in the Public Interest.
He also questioned the timing. "This is a wink and nod to the MAHA faithful in the hope that they'll show up at the polls," said Lurie, referring to Kennedy's 'Make America Healthy Again' movement. It is the latest example of Kennedy reshaping U.S. health policy in the MAHA mold. Some of the biggest figures in that movement sell peptide injections and supplements.
The decision is a stark break from FDA efforts to limit the availability of unproven wellness products. But that approach put the agency at odds with Kennedy, who has publicly endorsed the benefits of all of those products. Many in the U.S. who are using peptides today do not deal with a doctor or a pharmacy, but often order vials online sold by chemical manufacturers based in China. Peptide sellers often try to skirt U.S. regulations by labeling their products as 'for research use only'.
Lurie pointed out that the FDA, under federal law, does not have the authority to enforce the new pharmacy requirements. Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA. The tension remains between expanded patient access and the FDA's long-standing mission to keep unproven products off the market.
